Pyrogen Detection Kit for Rapid and Accurate Endotoxin Analysis

# Pyrogen Detection Kit for Rapid and Accurate Endotoxin Analysis

## Introduction to Pyrogen Detection Kits

Pyrogen detection kits are essential tools in pharmaceutical and medical device industries for ensuring product safety. These kits are designed to detect and quantify endotoxins, which are pyrogenic substances derived from the outer membrane of Gram-negative bacteria. Endotoxins can cause fever and other adverse reactions in humans, making their detection crucial for quality control.

## Why Choose Our Pyrogen Detection Kit?

Our Pyrogen Detection Kit offers several advantages for rapid and accurate endotoxin analysis:

– High sensitivity and specificity
– Fast results compared to traditional methods
– Easy-to-use format suitable for various applications
– Compliance with international regulatory standards

## Applications of Pyrogen Detection Kits

These kits find applications in multiple fields:

### Pharmaceutical Industry

Used for testing parenteral drugs, vaccines, and medical devices to ensure they are free from endotoxin contamination.

### Biotechnology

Essential for quality control of recombinant proteins, monoclonal antibodies, and other biopharmaceutical products.

### Medical Device Manufacturing

Critical for testing implants, surgical instruments, and other medical equipment that comes in contact with blood or sterile body sites.

## How the Kit Works

The Pyrogen Detection Kit utilizes a chromogenic or turbidimetric method based on the Limulus Amebocyte Lysate (LAL) principle. The process involves:

1. Sample preparation and dilution
2. Reaction with the LAL reagent
3. Measurement of color development or turbidity
4. Calculation of endotoxin concentration based on a standard curve

## Benefits of Rapid Endotoxin Analysis

Our kit provides significant time savings compared to traditional rabbit pyrogen tests:

– Results in 15-60 minutes versus several hours
– Reduced labor requirements
– Higher throughput capabilities
– Quantitative rather than qualitative results

## Technical Specifications

Parameter | Specification
Detection Range | 0.005-50 EU/mL
Sample Volume | 50-100 μL
Incubation Time | 15-60 minutes
Storage Conditions | 2-8°C

## Regulatory Compliance

Our Pyrogen Detection Kit meets the requirements of:

– USP Bacterial Endotoxins Test
– EP 2.6.14 Bacterial Endotoxins
– JP 4.01 Bacterial Endotoxins Test

## Ordering Information

For more details about our Pyrogen Detection Kit or to place an order, please contact our technical support team. We offer various kit sizes to accommodate different testing volumes and requirements.